On 21 November 2025, the Ministry of Health (MOH) adopted Order No. 1771, approving the Guidelines on HTA for Medical Devices (ST-N МОHU 42-9.2:2025), a significant step forward in aligning Ukraine’s health technology assessment (HTA) system with EU and international standards.
The Guidelines introduce the first dedicated methodology for evaluating medical devices, which is an area that was formally mandated in Ukrainian legislation but remained impossible to implement until now due to lack of methodological standards. The adoption of the Guidelines makes HTA requirements contained in the health-care legislation and Cabinet of Ministers Resolution No. 1300 (2020) operational.
1. Legal basis and background
Ukraine has progressively expanded its national HTA framework in the following way:
- The HTA was first introduced for pharmaceutical products and biologics through amendments to the Fundamentals of the Legislation on Healthcare (Law No. 2801-XII).
- The HTA was later extended to medical devices, providing a legal mandate for device-level HTA.
- The HTA for medical devices could not be conducted in practice without dedicated methodological guidance.
Resolution No. 1300 (2020) establishes the HTA process and requires that the HTA for medical devices be carried out by the authorised HTA body, the Ministry of Health’s State Expert Centre (SEC). Applicants must submit a dossier and the HTA body will prepare a draft conclusion, consult with the applicant and publish a non-confidential version. HTA conclusions are considered recommendations.
Ministry of Health Order No. 1771 now provides the missing methodology, enabling practical HTA implementation for medical devices.
2. Scope and purpose of the new Guidelines
2.1. Purpose of the Guidelines
The Guidelines set out the methodology, evidence requirements and dossier structure for conducting the state HTA for medical devices in Ukraine. Although not a regulatory act, the Guidelines serve as the official methodology applied by the authorised HTA body.
2.2. Scope of application (device categories covered)
The Guidelines apply to the state HTA for the following:
- Class IIb medical devices (medium–high risk);
- Class III medical devices (high risk);
- Class D in vitro diagnostic medical devices;
- Active implantable medical devices;
- Medical device software of Classes IIb and III.
Additional requirements:
- Devices must undergo Ukrainian conformity assessment; and
- The devices must be the first within their general device group placed on the market.
Important regulatory context
Framework referenced in the Guidelines are based on Ukraine’s current Technical Regulations, , which were originally developed using the structure and principles of the former EU Directives (93/42/EEC for medical devices, 90/385/EEC for active implantables, 98/79/EC for IVDs).
Ukraine is in the process of adopting new MDR- and IVDR-aligned Technical Regulations, which are currently being finalised and should be adopted soon, but will include long transitional periods, which means that the former EU-Directive classification rules will remain applicable for now.
2.3. Voluntary nature of HTA submissions
The state HTA of medical devices is voluntary. Applicants initiate the HTA by submitting an application and an HTA dossier (i.e. paper and electronic) prepared according to Section 5 of the Guidelines.
3. What the Guidelines cover: key features
3.1. Distinctive characteristics of medical devices
The Guidelines recognise specific factors requiring adapted HTA approaches, such as:
- Iterative design changes and frequent upgrades;
- User dependency (i.e. device performance varies with operator training and experience);
- Limited availability of robust clinical trial evidence, especially for operator-dependent or procedural technologies.
These features necessitate increased reliance on real-world evidence, analysis of learning curves, and tailored comparative and economic evaluations.
3.2. Structure and content of the HTA dossier
The dossier must address the following:
- Clinical effectiveness;
- Safety (i.e. risk related to devices, users and procedures);
- Economic evaluation (i.e. device lifecycle, maintenance, training, replacement);
- Budget impact analysis;
- Organisational impact (i.e. infrastructure, human resources, workflows);
- Ethical and social considerations.
3.3. Interaction with the HTA body
This process includes the following:
- Submission of application and dossier;
- Primary and expert review;
- Preparation of the draft HTA report;
- Publication of a redacted version on the HTA body’s website.
The new Guidelines provide practical and detailed methodological instructions for each step.
3.4. International alignment and EU convergence
The Guidelines are aligned with established international methodologies, including:
- EUnetHTA HTA Core Model 3.0;
- EUnetHTA Guideline on Therapeutic Medical Devices (2015);
- NICE (UK) HTA & medical technology evaluation manuals; and
- WHO Medical Device HTA Technical Series (2011, 2024).
This places Ukraine closer to alignment with EU Regulation 2021/2282 and modern European HTA practice.
4. Implications for medtech companies
4.1. Increased evidence expectations for manufacturers of devices
Manufacturers whose devices fall within the categories covered by the Guidelines should expect:
- More intensive scrutiny of clinical evidence;
- Requests for RWE, registries, usability studies, and learning-curve analyses;
- Detailed justification of equivalence claims;
- Full transparency regarding cost, modelling and underlying assumptions.
4.2. Impact on funding and procurement decisions
While Ukraine does not operate a unified medical device reimbursement list, HTA conclusions may influence:
- Public procurement decisions, particularly for complex or expensive technologies;
- Inclusion of device-based interventions in NHSU service packages;
- Prioritisation of technologies for state budgets and donor-funded programmes.
4.3. Immediate effect – no transition period
All HTA submissions filed after 21 November 2025 must comply with the new Guidelines. Manufacturers preparing dossiers for 2026 should adjust evidence strategies accordingly.
4.4. Market access planning
Medtech companies should do the following:
- Assess their HTA pathway early;
- Consider generating local evidence;
- Seek early scientific advice from the authorised HTA body (SEC).
5. Practical next steps for companies
Manufacturers should do the following:
- Map product portfolios against HTA-relevant categories;
- Align internal evidence and economic models with the new methodology;
- Monitor NHSU service package updates;
- Engage early with regulators for procedural clarity.
For more information on these Guidelines and opportunities in Ukraine’s health-care sector, contact your CMS client partner or the CMS expert: Borys Danevych.
